Compliance operations

Stop chasing compliance evidence. Let your operations produce it.

EquatorOps links every quality gate, change approval, and verification step to auditable evidence—so compliance is a by-product of operations, not a separate project.

200+

Table operational schema

15+

Domain provider layers

100%

Tenant-owned data

≤2s

Typical impact analysis computation

Evidence built into workflows

Every change approval, quality gate pass, and verification step generates immutable audit evidence—no separate compliance documentation effort.

Impact Intelligence for regulated changes

Preview change impact, template-driven verification packs, and NRE + recurring cost estimates before approving any change that touches regulated processes.

Framework-agnostic compliance

Map ISO 9001, ISO 13485, FDA 21 CFR Part 11, AS9100, IATF 16949, or any custom framework to platform-generated evidence.

Platform capabilities

Built for operational teams.

Quality gate engine

Define gates with pass/fail criteria, required evidence, and escalation rules. Gates auto-enforce during operational workflows.

View engines

Verification Graph Engine

Compute full change impact of any change across documents, SOPs, quality gates, suppliers, and work orders in under 2 seconds.

Impact Intelligence

Immutable audit trail

Every mutation—create, update, approve, reject—is recorded with timestamp, actor, and evidence hash. No edits, no deletions.

Security overview

Verification packs

Generate draft validation plans, document packages, acknowledgement tasks, and operation checklists for every change type.

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Industry applications

Trusted across regulated and complex operations.

Regulated manufacturing

ISO + quality gate alignment

Map quality gates to ISO clauses so every production step produces the evidence your QMS requires.

Healthcare & medical devices

FDA + DHF traceability

Link device history files, IQ/OQ/PQ protocols, and regulatory submissions to operational workflows.

Aerospace & defense

AS9100 + serialized traceability

Track serialized parts, configuration baselines, and airworthiness evidence across programs and depots.

Results

Operational outcomes you can measure.

Faster approvals. Fewer surprises. Audit-ready evidence without the scramble.

Faster change approvals

Less rework

Approve changes with change-impact preview + verification before execution.

Audit-ready evidence

Less scramble

Verification packs tie evidence to each change for partners and regulators.

Fewer inventory surprises

Fewer exceptions

One ledger across every site and custody change (serialized + bulk).

FAQ

Common questions.

How does EquatorOps integrate with our existing QMS?

EquatorOps doesn't replace your QMS—it feeds it. Quality gates, verification packs, and audit evidence export as structured data for integration with any quality management system.

Is the audit trail truly immutable?

Yes. Every event is append-only with cryptographic integrity. No retroactive edits, no deletions. The trail is tenant-owned and exportable for external audits.

Can we preview compliance impact before making changes?

Yes. Impact Intelligence runs in preview mode by default, showing change impact, verification work, and cost estimates before you commit to any change.

What compliance frameworks are supported?

The platform is framework-agnostic. Map any framework (ISO 9001, 13485, FDA 21 CFR Part 11, AS9100, IATF 16949, GMP, HACCP) to quality gates, evidence requirements, and verification workflows.

Get started

Map your compliance framework to operational evidence.

Schedule a focused workshop to connect quality gates, audit trails, and verification packs to your operational workflows.